MedTechLabel WP2 T2.2 Information Model Guide
0.4.15 - ci-build

MedTechLabel WP2 T2.2 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.15 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions

MedTechLabel

Official URL: http://www.hl7europe.org/medtechlabel/ImplementationGuide/medtechlabel Version: 0.4.15
Draft as of 2026-10-21 Computable Name: MedTechLabel

Please be aware that this page is still under construction and not final. Comments and further input are welcome.

Introduction

This is the starting page for the MedTechLabel project Information Model Guide (IG) that collects the necessary information for creating the information model for medical devices. It allows for collecting the information in interlinked fragments thus reducing duplication and overhead while finding a suitable representation of the details depending on their characteristics.

The primary purpose for now is to assemble:

In Sope

  • (basic) information model (with relations and attributes)
  • taxonomoy to organize artefacts
  • sample profiles

Out of Scope

  • process modelling
  • (complete) knowledge representation
    • conditions

Disclaimer

Although FHIR tools are used, it does not have any direct relation to/with FHIR.

Contributing

Contributions can be done via work package 2 of the MedTechLabel project.

Goal

The primary goal is to gather the requirements for labels for medical devices. This site collects the items that are to be considered and may appear (due to legal or standard requirements) on a digital label. Following a sample in landscape mode:


And now with some more explanations on the content. Of course, this sample is neither confirmed nor complete with regard to what it must contain or show:


Or, alternatively, more in portrait mode:


In the end, what will appear on a label is the result of the analysis.

Funding

This project is funded by the EU.

What is a medical device?

A medical device can be described in many ways:

  • identity
  • purpose
  • structure
  • function
  • behaviour
  • state
  • environment
  • lifecycle
  • relationships
  • governance
  • ..

This specification has to abstract from it in order to allow for providing all the ncessary details for a modelling.

Next Steps

The following issues are open as new steps and should be performed in the proposed order:

  • improve the Analysis (Excel) Sheet
    • traceable items (= library elements)
    • track occurence of conditions
  • analyse standards and verify analysis
    • check whether new items occur, update/improve analysis sheet if necessary
    • improve glossary of terms with references to standards from where they are taken
  • transfer data elements into the mindmap
  • update logical model to document details
  • update the information model itself (status: draft)
  • provide a notation to specify conditions
  • extract detailed conditions
  • Pratav: provide symbols as files
  • analyse other supplementary standards (to be provided)
    • eg. EMDN
  • …

This list can for the time being be taken as a plan for T2.2.

Open Topics and Questions

When working on this task (and deliverable) the following questions arose:

  • Who can do the detailed analysis for all standards?
  • How to validate the analyses?
  • How to use the detailed requirements to run an engine that validates the model?
  • How to deal with contradictory requirements in regulatory vs. standards?
  • What can be achieved with a digital label that a printed one cannot?
  • How to envision and include future requirements and expectations into the current model?
    • We identify a lot of topics that are relevant but cannot be addressed within the limits of this project!
    • Building the foundational framework and ontology is very limited.

Remaining Notes to reconcile

label:

  • content? where?

questions:

  • add "under construction" icon on top of IG
  • add process and actors to taxonomy, color-code diagram

requirements:

  • abstract
    • access to digital implant cards without passwort
  • symbols
    • = icon + text + originating standard + standard using it + condition(s) when to use
    • specific requirements associated with a symbol -> submodel
    • clarify whether an icon can be added to a code in a codesystem, eg in a property by extensions!?
    • list of all symbols provided as a file to include in IG

logical model for:

  • abstract label
    • form
      • digital label
        • identifier, URL
      • printed label
        • attached to package/container/device
      • hybrid
    • requirements as profiles derived from it
      • name: reference the originating clause
      • add addtl explanations
      • add constraints
  • specialisations as derived logical model?

additional columns for library/artefacts list:

  • providedBy (realized by relatedTo?)

glossary: https://glossary.i-hd.eu/guest-page

Results of this Task

The report (D2.2?) from this task (WP2 T2.2) may use the following structure:

  1. introduction 1.1 scope 1.2 input
    • legislation
    • standards
  2. methodology
  3. results 3.1. input data 3.2. taxonomy 3.3. conditions 3.4. information model 3.5. profiling the model
  4. annexes
    • codesystem with properties as FHIR resource
    • glossary

Overview about Regulations

Regulation Title Status Purpose Consideration Comment
EUDAMED   open      
EMDN European Medical Device Nomenclature open     may provide supplementary information, esp. for glossary
EU MDD Medical Device Directive open      
EU MDR Medical Device Regulation open      
IVDR Implantable Devices open      
IMDRF International Medical Device Regulators Forum open      
FDA 21 CFR Part 820   open      
UDI Unique Device Identification open      

Overview about Standards

Following some standards that may or may not be of relevance:

Standard Title Status Purpose Consideration Comment
ISO 639 Code for individual languages and language groups open      
ISO 780 Packaging — Distribution packaging — Graphical symbols for handling and storage of packages open      
ISO 3166 Country codes open      
ISO 3864-1:2011 ´Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs and safety markings open      
ISO 7000 Graphical Symbols for use on Equipment, e.g. 1641 open Content: Icons supporting  
ISO 7010:2019 Graphical symbols — Safety colours and safety signs — Registered safety signs, e.g. M001, P001 open Content: Icons supporting  
ISO 8601-1 Date and time — Representations for information interchange — Part 1: Basic rules´ open      
ISO 9001:2015 Quality Management Systems - Fundamentals and vocabulary open      
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes open      
ISO 14617-2:2025 Graphical symbols for diagrams - Part 2: Graphical symbols open      
ISO 14971 Risk Management Process open Content and semantics
Assurance and decisions		 supporting  
ISO 15223 Medical devices — Symbols to be used with information to be supplied by the manufacturer open Presentation
Content and semantics		 primary  
ISO 17664 Processing instructions and supporting validation open Information set
Assurance and decisions		 supporting  
ISO 18113, Parts 1-5 IVD information by product and intended user open Product and use profile
Content and semantics		 primary  
ISO/IEC 18975 Internet links from product identifcation open Access service
Content and Semantics		 primary  
ISO 20417:2026 ´Medical devices — Information to be supplied by the manufacturer to be included Product and use profile
Content and semantics		 primary used as pilot for analysis
ISO 22742:2010 QR Code open      
ISO 23903 Semantics architecture and model relationships open Content and semantics
Assurance and decisions		 primary  
ISO 24884 Electronic IFU delivery for IVDs open Information set
Access service		 primary  
EN 50419 Electrical equipment marking and conditiona locations open Presentation
Assurance and decisions		 supporting  
IEC 60601-1
IEC 61010-1		 Equipment safety information within the applicable scope open Product and use profile
Content and semantics		 supporting  
ISO/IEC 62304 Medical device software — Software life cycle processes open Assurance and decisions
Information set		 supporting  
ISO 62366 Usability evidence for information and interaction open Presentation
Assurance and decisions		 supporting  
IEC/IEEE 82079-1 Information quality and preparation for intended use open Content and semantics
Presentation		 supporting  
ISO/IEC 82304-1 Health software information and product assurance open Information set
Assurance and decisions		 primary  
BS EN 1041:2008 requirements for information to be supplied by a manufacturer for medical devices outdated     replaced by newer rules like ISO 20417 under modern EU medical regulations

The following links may be helpful for further analysis:

  • http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf
  • http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-pl-md-ivd.pdf
  • https://www.johner-institut.de/blog/wp-content/uploads/2020/02/MDR_konsolidiert.html
  • https://www.johner-institut.de/blog/wp-content/uploads/2020/01/IVDR_konsolidiert.html
  • https://blog.hl7.org/hl7-launches-caliper-a-new-fhir-accelerator-advancing-real-time-medical-device-interoperability
  • Regulation (EU) 2017/745 on medical devices (MDR): https://eur-lex.europa.eu/eli/reg/2017/745/2025-01-10
  • Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices: https://eur-lex.europa.eu/eli/reg/2017/746/2025-01-10
  • EMDN codes: https://webgate.ec.europa.eu/udi-helpdesk/en/other-relevant-information/emdn-codes.html
  • Johner Institut